Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy

Prospective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®

Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. To evaluate the clinical profile of this drug combination under routine medical condition, a post-authorization safety study required by Mexican Health Authorities will be conducted in Mexican women.

The study will be performed as a descriptive study, no hypothesis will be tested. The cohort consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical conditions. Subjects should provide all necessary information on health-related events or changes in health status during Qlaira use.

Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or not related to Qlaira during at least 2 years of observation.

In order to comply with the criteria of a non-interventional study, women only will be informed about the study, asked to participate and included in the study after Qlaira has been prescribed.

Study patients follow-up will be done in accordance with common clinical practice as described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM 005-SSA2-1993).

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: EV/DNG (Qlaira, BAY86-5027)

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Mexico
  • Multiple Locations, Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Cohort of healthy women of reproductive age currently Qlaira users from selected obstetrics and gynecology (Ob/Gyn) primary care clinics

Description

Inclusion Criteria:

Healthy women of reproductive age who are:

• Seeking fertility control with oral contraception at least for one year
• Able to go back to medical office on regular basis

Exclusion Criteria:

Women with risk parameters of arterial or venous thrombotic diseases such as:

• Smoke, if over age 35
• Deep vein thrombosis or pulmonary embolism, now or in the past
• Cerebrovascular disease
• Coronary artery disease
• Thrombogenic valvular or thrombogenic rhythm diseases of the heart
• Inherited or acquired hypercoagulopathies
• Uncontrolled hypertension
• Diabetes with vascular disease
• Headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
• Undiagnosed abnormal genital bleeding
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
• Liver tumors, benign or malignant, or liver disease
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Group 1; Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets.

Drug: EV/DNG (Qlaira, BAY86-5027); Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety variables will be summarized using descriptive statistics based on adverse events collection	After 24 months
Continuation rate, as proportion of patients still using Qlaira	After 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reasons for discontinuation related or unrelated to adverse events	After 24 months
Patient satisfaction with Qlaira	After 24 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2015
• Primary Completion (Actual): May 17, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: May 18, 2012
• First Submitted That Met QC Criteria: May 18, 2012
• First Posted (Estimate): May 21, 2012

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Adverse events; Oral contraceptives; Contraceptive Agents; Safety profile
• Other Study ID Numbers: 16233; QL1210MX (Other Identifier: company internal)